| CTRI Number |
CTRI/2026/01/100504 [Registered on: 07/01/2026] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Unani drug in comparison to Mefenamic Acid in Primary Dysmenorrhoea |
|
Scientific Title of Study
|
Efficacy of Izkhar versus Mefenamic acid in primary dysmenorrhea- A Randomized Standard Controlled Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nahid Parveen |
| Designation |
PG Scholar |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
National Institute Of Unani Medicine kottigepalya Magadi Main Road Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
9565202983 |
| Fax |
|
| Email |
miss.nahidparveen786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Ismath Shameem |
| Designation |
Professor and HoD |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
ROOM No 29 National Institute Of Unani Medicine kottigepalya Magadi Main Road Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
9449977008 |
| Fax |
|
| Email |
dr.ismaths@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Ismath Shameem |
| Designation |
Professor and HoD |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Room No 29 National Institute Of Unani Medicine kottigepalya Magadi Main Road Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
9449977008 |
| Fax |
|
| Email |
dr.ismaths@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bengaluru India 560091 |
|
|
Primary Sponsor
|
| Name |
National Institute Of Unani Medicine |
| Address |
National Institute Of Unani Medicine,Kottigepalya,Magadi main road,Bengaluru 560091 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nahid Parveen |
National Institute Of Unani Medicine |
Room No 29 Ilmul Qabalat Wa Amraze Niswan
Bangalore
KARNATAKA |
9565202983
miss.nahidparveen786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethics Committee for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Izkhar |
After procurement and identification of Izkhar,decoction of Izkhar will be prepared by soaking 10g in 200ml of water overnight. The infusion will be boiled the following morning until it reduces to half and will be administered orally on an empty stomach from D1-D5 of the menstruation for 3 consecutive cycles |
| Comparator Agent |
Mefenamic Acid |
Tab. Mefenamic Acid 500mg orally will be given SOS from D1-D5 of the menstruation for 3 consecutive cycle |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Participants in the age of 15-35 years having painful menstruation of 1 to 2 episodes with VAS score (4-7) and VMSS score (1-2), with or without the associated symptoms (nausea, vomiting, fatigue, headache, giddiness, tenderness). |
|
| ExclusionCriteria |
| Details |
Pelvic pathology like uterine fibroid, endometriosis, adenomyosis, PID, PCOD, Systemic illnesses like HTN, DM, malignancies, Acute abdominal conditions like Peritonitis, Appendicitis, Renal and GB calculi, Heavy menstrual bleeding and severe anemia. Pregnant and lactating women
Ectopic Pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in VAS score and VMSS grading |
Baseline 4 week 8 week 12 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients diagnosed with primary dysmenorrhea will be randomly allocated in test (n = 25) and control (n = 25) groups after obtaining written informed consent. The study will be conducted in an open labelled manner. In test group, decoction of Izkhar will be prepared by soaking 10g in 200ml of water overnight. The infusion will be boiled the following morning until it reduces to half and will be administered orally on an empty stomach from D1-D5 of the menstruation for three consecutive cycles. In the control group, Mefenamic acid (500 mg) will be given SOS. Participants will be followed before and after menstruation during treatment and once after the completion of the treatment. Reduction in Visual Analogue Scale (VAS) and the Verbal Multidimensional Scoring System (VMSS) will be assessed during the study. |